Biotech Stocks Facing FDA Decision In March 2022

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bluebird bio
bluebird bio

An FDA advisory committee is scheduled to review bluebird bio Inc.‘s (BLUE) investigational gene therapy Betibeglogene autotemcel on March 9.

Betibeglogene autotemcel, also known as Beti-cel in short, is proposed for the treatment of adult, adolescent, and pediatric patients with ß-thalassemia across all genotypes who require regular red blood cell transfusions.

If approved, Beti-cel will be the first one-time treatment that addresses the underlying genetic cause of disease for patients living with ß-thalassemia in the U.S. - offering an alternative to regular RBC transfusions and iron chelation therapy.

The final decision of the FDA is expected on August 19.

Beti-cel was approved in Europe, under the name Zynteglo, in June 2019, with a list price of $1.8 million. With the company winding down its operations in Europe last October, Zynteglo has been withdrawn from both the EU and the UK.

BLUE closed Friday's (Feb.25, 2022) trading at $6.17, unchanged from the previous day's close.